Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system

Stefan Verheye, Mathias Vrolix, Matteo Montorfano, Carlo Zivelonghi, Francesco Giannini, Francesco Bedogni, Christophe Dubois, Bernard De Bruyne, Ricardo A. Costa, Daniel Chamié, José Ribamar Costa, Dean J. Kereiakes, Alexandre Abizaid, Antonio Colombo

Research output: Contribution to journalArticlepeer-review

Abstract

Aims: We aimed to assess the safety and efficacy of the DynamX Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements. Methods and results: This multicentre study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Up to 12 months, two target lesion failures occurred: Both were cardiac deaths (day 255 and day 267 post procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm indevice and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility, with an approximate lumen area variance of 11% between systole and diastole. Conclusions: The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy up to one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomised trials are required to assess the benefit of this device on events beyond one year.

Original languageEnglish
Pages (from-to)E974-E981
JournalEuroIntervention
Volume16
Issue number12
DOIs
Publication statusPublished - 2020

Keywords

  • Clinical research
  • Miscellaneous
  • Other technique
  • Stable angina

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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